Randomized Trial of a Supportive Care Mobile Application to Improve Symptoms, Coping, and Quality of Life in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Study feasibility based on rates of participant recruitment and completion of assigned study procedures
研究概览
简要总结
This research study is looking at the role of a supportive care mobile app in improving symptoms, coping skills, and quality of life in patients with non-small cell lung cancer.
详细描述
This research study is a Feasibility Study, which is the first-time investigators are examining this supportive care mobile app intervention. The goal of this research study is to refine and examine the feasibility and benefits of a supportive care mobile app to improve symptoms, coping skills, and quality of life in patients with non-small cell lung cancer. Many people diagnosed with lung cancer experience challenging symptoms and increased stress. To help address these concerns, this study is exploring how a mobile application (app) intervention, designed specifically for people with lung cancer, can expand the availability of much needed supportive care services.
The research study procedures include:
- A supportive care mobile app consisting of six intervention modules that focus on components of wellbeing, such as physical, social, functional, and emotional wellbeing
- Questionnaires asking about demographic information (e.g., gender, ethnicity, income) and participants' experience with cancer (e.g., quality of life, symptoms)
- Data collection from participants medical records
After completing a baseline study questionnaire, participants will be randomized into two (2) study groups:
- Usual Care Group: Participants will receive standard oncology care and attend their regular clinic visits. Study staff will monitor participant use of supportive care services.
- Intervention Group: Participants will be provided with a study-issued tablet computer to access the mobile app and receive tutorial and instructions for how to use the app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Diagnosed with unresectable Stage III or IV NSCLC in the past twelve weeks and receiving care with palliative intent (per clinician documentation in the electronic health record)
- •Eastern Cooperative Oncology Group Performance Status = 0-3
- •Plan to receive oncology care at one of the participating study sites
- •Ability to read and respond to questions in English
排除标准
- •Significant uncontrolled psychiatric disorder (e.g., psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (e.g., dementia, cognitive impairment), which the treating oncology clinician reports would prohibit the ability to participate in study procedures
结局指标
主要结局
Study feasibility based on rates of participant recruitment and completion of assigned study procedures
时间窗: 12 weeks
Study feasibility will be defined as ≥ 65% approach-to-enrollment rate of eligible participants and ≥70% completion rate of study procedures (at least four mobile app modules and assigned study questionnaires)
次要结局
- Compare patient-reported coping between study groups on the Brief COPE Scale(12 weeks)
- Compare patient-reported quality of life between study groups on the Functional Assessment of Cancer Therapy-Lung Scale(12 weeks)
- Compare patient-reported psychological distress between study groups on the Hospital Anxiety and Depression Scale(12 weeks)
- Patient-reported acceptability and usability of the mobile application intervention on the System Usability Scale(12 weeks)
- Compare patient-reported symptoms between study groups on the MD Anderson Symptom Inventory(12 weeks)
研究者
Joseph A. Greer, Ph.D.
Principal Investigator
Massachusetts General Hospital